[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4281 Received in Senate (RDS)]
2d Session
H. R. 4281
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 18 (legislative day, September 22), 2000
Received
_______________________________________________________________________
AN ACT
To establish, wherever feasible, guidelines, recommendations, and
regulations that promote the regulatory acceptance of new or revised
scientifically valid toxicological tests that protect human and animal
health and the environment while reducing, refining, or replacing
animal tests and ensuring human safety and product effectiveness.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``ICCVAM Authorization Act of 2000''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Alternative test method.--The term ``alternative test
method'' means a test method that--
(A) includes any new or revised test method; and
(B)(i) reduces the number of animals required;
(ii) refines procedures to lessen or eliminate pain
or distress to animals, or enhances animal well-being;
or
(iii) replaces animals with non-animal systems or 1
animal species with a phylogenetically lower animal
species, such as replacing a mammal with an
invertebrate.
(2) ICCVAM test recommendation.--The term ``ICCVAM test
recommendation'' means a summary report prepared by the ICCVAM
characterizing the results of a scientific expert peer review
of a test method.
SEC. 3. INTERAGENCY COORDINATING COMMITTEE ON THE VALIDATION OF
ALTERNATIVE METHODS.
(a) In General.--With respect to the interagency coordinating
committee that is known as the Interagency Coordinating Committee on
the Validation of Alternative Methods (referred to in this Act as
``ICCVAM'') and that was established by the Director of the National
Institute of Environmental Health Sciences for purposes of section
463A(b) of the Public Health Service Act, the Director of the Institute
shall designate such committee as a permanent interagency coordinating
committee of the Institute under the National Toxicology Program
Interagency Center for the Evaluation of Alternative Toxicological
Methods. This Act may not be construed as affecting the authorities of
such Director regarding ICCVAM that were in effect on the day before
the date of the enactment of this Act, except to the extent
inconsistent with this Act.
(b) Purposes.--The purposes of the ICCVAM shall be to--
(1) increase the efficiency and effectiveness of Federal
agency test method review;
(2) eliminate unnecessary duplicative efforts and share
experiences between Federal regulatory agencies;
(3) optimize utilization of scientific expertise outside
the Federal Government;
(4) ensure that new and revised test methods are validated
to meet the needs of Federal agencies; and
(5) reduce, refine, or replace the use of animals in
testing, where feasible.
(c) Composition.--The ICCVAM shall be composed of the heads of the
following Federal agencies (or their designees):
(1) Agency for Toxic Substances and Disease Registry.
(2) Consumer Product Safety Commission.
(3) Department of Agriculture.
(4) Department of Defense.
(5) Department of Energy.
(6) Department of the Interior.
(7) Department of Transportation.
(8) Environmental Protection Agency.
(9) Food and Drug Administration.
(10) National Institute for Occupational Safety and Health.
(11) National Institutes of Health.
(12) National Cancer Institute.
(13) National Institute of Environmental Health Sciences.
(14) National Library of Medicine.
(15) Occupational Safety and Health Administration.
(16) Any other agency that develops, or employs tests or
test data using animals, or regulates on the basis of the use
of animals in toxicity testing.
(d) Scientific Advisory Committee.--
(1) Establishment.--The Director of the National Institute
of Environmental Health Sciences shall establish a Scientific
Advisory Committee (referred to in this Act as the ``SAC'') to
advise ICCVAM and the National Toxicology Program Interagency
Center for the Evaluation of Alternative Toxicological Methods
regarding ICCVAM activities. The activities of the SAC shall be
subject to provisions of the Federal Advisory Committee Act.
(2) Membership.--
(A) In general.--The SAC shall be composed of the
following voting members:
(i) At least 1 knowledgeable representative
having a history of expertise, development, or
evaluation of new or revised or alternative
test methods from each of--
(I) the personal care,
pharmaceutical, industrial chemicals,
or agriculture industry;
(II) any other industry that is
regulated by the Federal agencies
specified in subsection (c); and
(III) a national animal protection
organization established under section
501(c)(3) of the Internal Revenue Code
of 1986.
(ii) Representatives (selected by the
Director of the National Institute of
Environmental Health Sciences) from an academic
institution, a State government agency, an
international regulatory body, or any
corporation developing or marketing new or
revised or alternative test methodologies,
including contract laboratories.
(B) Nonvoting ex officio members.--The membership
of the SAC shall, in addition to voting members under
subparagraph (A), include as nonvoting ex officio
members the agency heads specified in subsection (c)
(or their designees).
(e) Duties.--The ICCVAM shall, consistent with the purposes
described in subsection (b), carry out the following functions:
(1) Review and evaluate new or revised or alternative test
methods, including batteries of tests and test screens, that
may be acceptable for specific regulatory uses, including the
coordination of technical reviews of proposed new or revised or
alternative test methods of interagency interest.
(2) Facilitate appropriate interagency and international
harmonization of acute or chronic toxicological test protocols
that encourage the reduction, refinement, or replacement of
animal test methods.
(3) Facilitate and provide guidance on the development of
validation criteria, validation studies and processes for new
or revised or alternative test methods and help facilitate the
acceptance of such scientifically valid test methods and
awareness of accepted test methods by Federal agencies and
other stakeholders.
(4) Submit ICCVAM test recommendations for the test method
reviewed by the ICCVAM, through expeditious transmittal by the
Secretary of Health and Human Services (or the designee of the
Secretary), to each appropriate Federal agency, along with the
identification of specific agency guidelines, recommendations,
or regulations for a test method, including batteries of tests
and test screens, for chemicals or class of chemicals within a
regulatory framework that may be appropriate for scientific
improvement, while seeking to reduce, refine, or replace animal
test methods.
(5) Consider for review and evaluation, petitions received
from the public that--
(A) identify a specific regulation, recommendation,
or guideline regarding a regulatory mandate; and
(B) recommend new or revised or alternative test
methods and provide valid scientific evidence of the
potential of the test method.
(6) Make available to the public final ICCVAM test
recommendations to appropriate Federal agencies and the
responses from the agencies regarding such recommendations.
(7) Prepare reports to be made available to the public on
its progress under this Act. The first report shall be
completed not later than 12 months after the date of the
enactment of this Act, and subsequent reports shall be
completed biennially thereafter.
SEC. 4. FEDERAL AGENCY ACTION.
(a) Identification of Tests.--With respect to each Federal agency
carrying out a program that requires or recommends acute or chronic
toxicological testing, such agency shall, not later than 180 days after
receiving an ICCVAM test recommendation, identify and forward to the
ICCVAM any relevant test method specified in a regulation or industry-
wide guideline which specifically, or in practice requires, recommends,
or encourages the use of an animal acute or chronic toxicological test
method for which the ICCVAM test recommendation may be added or
substituted.
(b) Alternatives.--Each Federal agency carrying out a program
described in subsection (a) shall promote and encourage the development
and use of alternatives to animal test methods (including batteries of
tests and test screens), where appropriate, for the purpose of
complying with Federal statutes, regulations, guidelines, or
recommendations (in each instance, and for each chemical class) if such
test methods are found to be effective for generating data, in an
amount and of a scientific value that is at least equivalent to the
data generated from existing tests, for hazard identification, dose-
response assessment, or risk assessment purposes.
(c) Test Method Validation.--Each Federal agency carrying out a
program described in subsection (a) shall ensure that any new or
revised acute or chronic toxicity test method, including animal test
methods and alternatives, is determined to be valid for its proposed
use prior to requiring, recommending, or encouraging the application of
such test method.
(d) Review.--Not later than 180 days after receipt of an ICCVAM
test recommendation, a Federal agency carrying out a program described
in subsection (a) shall review such recommendation and notify the
ICCVAM in writing of its findings.
(e) Recommendation Adoption.--Each Federal agency carrying out a
program described in subsection (a), or its specific regulatory unit or
units, shall adopt the ICCVAM test recommendation unless such Federal
agency determines that--
(1) the ICCVAM test recommendation is not adequate in terms
of biological relevance for the regulatory goal authorized by
that agency, or mandated by Congress;
(2) the ICCVAM test recommendation does not generate data,
in an amount and of a scientific value that is at least
equivalent to the data generated prior to such recommendation,
for the appropriate hazard identification, dose-response
assessment, or risk assessment purposes as the current test
method recommended or required by that agency;
(3) the agency does not employ, recommend, or require
testing for that class of chemical or for the recommended test
endpoint; or
(4) the ICCVAM test recommendation is unacceptable for
satisfactorily fulfilling the test needs for that particular
agency and its respective congressional mandate.
SEC. 5. APPLICATION.
(a) Application.--This Act shall not apply to research, including
research performed using biotechnology techniques, or research related
to the causes, diagnosis, treatment, control, or prevention of physical
or mental diseases or impairments of humans or animals.
(b) Use of Test Methods.--Nothing in this Act shall prevent a
Federal agency from retaining final authority for incorporating the
test methods recommended by the ICCVAM in the manner determined to be
appropriate by such Federal agency or regulatory body.
(c) Limitation.--Nothing in this Act shall be construed to require
a manufacturer that is currently not required to perform animal testing
to perform such tests. Nothing in this Act shall be construed to
require a manufacturer to perform redundant endpoint specific testing.
(d) Submission of Tests and Data.--Nothing in this Act precludes a
party from submitting a test method or scientific data directly to a
Federal agency for use in a regulatory program.
Passed the House of Representatives October 17, 2000.
Attest:
JEFF TRANDAHL,
Clerk.